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Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer

Primary Purpose

Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
photodynamic therapy
therapeutic conventional surgery
laboratory biomarker analysis
temoporfin
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery
  • Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
  • Life expectancy of at least 6 months in the judgment of the physician
  • Blood urea nitrogen (BUN) =< upper limit of normal (ULN)
  • White blood count > 3,000 per microliter or
  • Absolute neutrophil count (ANC) > 1500 per microliter
  • Serum calcium within normal limits; note: serum calcium will be corrected for low albumin, if necessary
  • Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Subjects who have had radiotherapy within the last 3 months
  • Subjects with known brain metastases should be excluded from this clinical trial
  • Tumor invading a major blood vessel (such as the carotid artery)
  • Tumor invading the skull base
  • Subjects with ophthalmic disease
  • Tumor is not clearly shown on an imaging scan/location and extension of tumor that precludes effective PDT, in the judgment of the primary investigator (PI)
  • Location and extension of the tumor precludes an effective interstitial photodynamic therapy (iPDT)
  • Patients with known hypersensitivity to porphyrins or with porphyria
  • Has distant metastasis that decreases life expectancy to less than 6 months
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or nursing female subjects
  • Unwilling or unable to follow protocol requirements and the light exposure precautions
  • Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (interstitial photodynamic therapy using temoporfin)

    Arm Description

    Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.

    Outcomes

    Primary Outcome Measures

    Frequency of adverse events, graded according to NCI CTCAE version 4.0
    The frequency of toxicities will be tabulated by grade.

    Secondary Outcome Measures

    Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
    Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
    The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.

    Full Information

    First Posted
    October 29, 2012
    Last Updated
    September 2, 2014
    Sponsor
    Roswell Park Cancer Institute
    Collaborators
    National Institutes of Health (NIH), Biolitec Pharma Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01718223
    Brief Title
    Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer
    Official Title
    A Pilot Study of Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    implementation issues
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Roswell Park Cancer Institute
    Collaborators
    National Institutes of Health (NIH), Biolitec Pharma Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Detailed Description
    PRIMARY OBJECTIVES: I. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0). SECONDARY OBJECTIVES: I. Quantify the relationship between the measured intra-tumor light dose and the pathological tumor response. TERTIARY OBJECTIVES: I. Simulate light dose distribution within the treated tumor. II. Immune markers. OUTLINE: Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection. After completion of study treatment, patients are followed for 3 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (interstitial photodynamic therapy using temoporfin)
    Arm Type
    Experimental
    Arm Description
    Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
    Intervention Type
    Drug
    Intervention Name(s)
    photodynamic therapy
    Other Intervention Name(s)
    Light Infusion Therapy™, PDT, therapy, photodynamic
    Intervention Description
    Undergo interstitial photodynamic therapy using temoporfin
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic conventional surgery
    Intervention Description
    Undergo surgical resection
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Description
    Correlative studies
    Intervention Type
    Drug
    Intervention Name(s)
    temoporfin
    Other Intervention Name(s)
    Foscan, m-tetrahydroxyphenyl-chlorin, mTHPC
    Intervention Description
    Undergo interstitial photodynamic therapy using temoporfin
    Primary Outcome Measure Information:
    Title
    Frequency of adverse events, graded according to NCI CTCAE version 4.0
    Description
    The frequency of toxicities will be tabulated by grade.
    Time Frame
    Up to 30 days after surgical resection
    Secondary Outcome Measure Information:
    Title
    Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
    Time Frame
    Day 3
    Title
    Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
    Description
    The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.
    Time Frame
    Up to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician) Life expectancy of at least 6 months in the judgment of the physician Blood urea nitrogen (BUN) =< upper limit of normal (ULN) White blood count > 3,000 per microliter or Absolute neutrophil count (ANC) > 1500 per microliter Serum calcium within normal limits; note: serum calcium will be corrected for low albumin, if necessary Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Subjects who have had radiotherapy within the last 3 months Subjects with known brain metastases should be excluded from this clinical trial Tumor invading a major blood vessel (such as the carotid artery) Tumor invading the skull base Subjects with ophthalmic disease Tumor is not clearly shown on an imaging scan/location and extension of tumor that precludes effective PDT, in the judgment of the primary investigator (PI) Location and extension of the tumor precludes an effective interstitial photodynamic therapy (iPDT) Patients with known hypersensitivity to porphyrins or with porphyria Has distant metastasis that decreases life expectancy to less than 6 months Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or nursing female subjects Unwilling or unable to follow protocol requirements and the light exposure precautions Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hassan Arshad, MD
    Organizational Affiliation
    Roswell Park Cancer Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer

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